To regulate health apps, which are mushrooming day by day, Food and Drug Administration USA (USFDA) has come out with draft regulations. The agency said it will be focusing only on select group of apps and that the sale of smartphones or tablets would be left untouched.
The mobile medical apps currently available in the market may range between anything including helping users watch their calorie intake or sending their radiology images to the doctors.
The move by USFDA may be a precursor of similar steps by Indian government agencies as well. For example, only some time ago the Insurance Regulatory Authority of India (IRDA) had come out with draft regulations to regulate the functioning of web aggregators of Insurance services in India. In the same vein, we can expect similar regulations for mobile medical apps from Indian authorities as well.
The USFDA has asked general public for comments on this draft. “The use of mobile medical apps on smart phones and tablets is revolutionising health care delivery,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
“Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”